AMNOG Guides
Evergreen guides to the key elements of the German AMNOG process.
AMNOG guides to the process and dossier
Appropriate comparator therapy (zVT): relevance for the AMNOG process and benefit assessment
The zweckmäßige Vergleichstherapie (zVT) is the comparator defined by Germany's Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) for assessing the additional benefit of a new medicine under the AMNOG process. It therefore has a direct bearing on which clinical evidence
Written comments and the G-BA oral hearing in the German AMNOG process
Written comments and the G-BA oral hearing allow outstanding assessment issues to be addressed after publication of the German benefit assessment and before the final G-BA resolution. For international market access teams, these steps are important because the published IQWiG or
G-BA consultation: Preparation and early market access planning for Germany
Market access planning for Germany should ideally start before clinical development is complete. For the later German early benefit assessment, it matters whether the study population, comparator, patient-relevant outcomes and analyses can address the German assessment question. Once pivotal studies are complete, important evidence gaps may be difficult to correct. Consultation with Germany’s Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is therefore an important early component of market access planning for Germany.
AMNOG dossier: Structure, modules and requirements for benefit assessment
The AMNOG dossier, often called the German value dossier or HTA dossier for Germany, is the structured evidence submission prepared by the pharmaceutical company for the early benefit assessment under Section 35a SGB V. It consists of five modules and combines information on the medicinal product and the German healthcare context with the clinical evidence on added benefit and the underlying documents and supporting evidence.
AMNOG process in Germany: benefit assessment, evidence requirements and preparation
The AMNOG process is Germany's national pathway for the early benefit assessment of new medicines and the subsequent determination of a reimbursed price. For international market access and evidence teams, the key point is that AMNOG is not simply a post-launch dossier exercise.